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Aphasia, AcquiredNCT05667480

VR and Script Training of PWA

A study testing VR-based script training and Conventional script training in people with Aphasia, Acquired and Chronic Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this intervention study is to investigate the effects of immersive virtual reality in rehabilitation of language and communication of individuals with post-stroke aphasia. The main research questions are: 1. Is VR-based script training a feasible treatment to Cantonese-speaking PWA? 2. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Aphasia, Acquired, Chronic Stroke
What is being tested?
VR-based script training and Conventional script training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteHong Kong
Study dates
10 Apr 2023to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • a stroke onset more than six months, with an Aphasia Quotient (AQ) below 96.4, as evaluated by the Cantonese version of Western Aphasia Battery (CAB; Yiu, 1992),
  • premorbid fluent Cantonese speakers,
  • aged between 30 and 80 years,
  • no reported progressive neurogenic disorders such as dementia or Parkinson's disease,
  • no motor speech disorders of moderate to severe level, and
  • normal or corrected-to-normal vision and hearing functions

Who cannot join

  • concurrent participation in other aphasia treatment trials, and
  • incompatibility with immersive VR exposure such as complains of nausea, headache, or other severe discomforts during trial use of a head-mounted device during screening.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Hong Kong Polytechnic University

    Hong Kong, Hong Kong SAR, 852

Other trials in Hong Kong

About this study

Official title: Utilization of Immersive Virtual Reality in Computerized Script Training for People with Aphasia: a Feasibility Study

The goal of this intervention study is to investigate the effects of immersive virtual reality in rehabilitation of language and communication of individuals with post-stroke aphasia. The main research questions are:

  1. Is VR-based script training a feasible treatment to Cantonese-speaking PWA?
  2. Will VR-based script training, when compared to conventional script training, better enhance treatment outcomes in functional communication of PWA?
Read more

Participants will be assessed before, in the middle of, immediately after treatment and 8-week post treatment in terms of their performance on:

  1. Accuracy and time for producing trained scripts.
  2. Accuracy and time for producing un-trained scripts
  3. Standardized aphasia test on severity of language impairment
  4. Standardized aphasia test on functional communication

The participants will be randomly allocated to receive one of the treatment:

  1. Virtual reality-based computerized script training; or
  2. Computerized script training without virtual reality Researchers will compare the treatment outcomes of the two treatment conditions and see if treatment with virtual reality would better promote outcomes when compared to training without virtual reality.
Being tested
VR-based script training, Conventional script training
Keywords
functional communication, randomized study, script training, immersive virtual reality, aphasia intervention
Medical subject headings
Aphasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VR-based script trainingBehavioural

    The PWA will wear a head-mounted VR device (e.g., Metaverse Oculus Quest 2 or other commercially available devices) for 30 minutes, which intends to create an immersive environment for training. Scripts trained in the computerized script training program in a particular session will be practiced. Cinematic 360˚ photo-real scenarios of daily contexts such as a restaurant or a grocery store will be displayed in the device while a communication partner, e.g., a waiter in the restaurant or a shopkeeper of a grocery store will initiate the conversation by producing the corresponding part of the script. The PWA will be given time to respond. Upon the completion of PWA's respond, the next conversational turn will be initiated. The clinical assistant, who accompanies the PWA in the entire training session, will control the flow of the 360 ˚ videos.

  • Conventional script trainingBehavioural

    The flow of training is identical to the VR condition, except that photos depicting the scenarios and pre-recorded conversational turns will be presented to the PWA on a computer screen with the same procedures mentioned in the VR condition.

Study groups in NCT05667480
Study groupRoleWhat they receive
VR-based script trainingExperimentalNot described
Receives: Behavioral: VR-based script training
Conventional script trainingActive comparatorNot described
Receives: Behavioral: Conventional script training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage correct in reading aloud the sentences included in the trained scripts

    Trained scripts will be shown in written form while the PWA will be asked to read aloud the scripts.

    Measured: From baseline up to 1-week post training

  2. Time required in read aloud of trained scripts

    Total time to read aloud the trained scripts

    Measured: From baseline up to 1-week post training

  3. Percentage correct in spontaneous production of the sentences included in the trained scripts

    No written cue will be provided while the PWA will produce the scripts upon questions.

    Measured: From baseline up to 1-week post training

  4. Time required for spantaneous production of trained scripts

    No written cue will be provided while the PWA will produce the scripts upon questions.

    Measured: From baseline up to 1-week post training

Secondary outcomes (3)
  1. CAB

    Cantonese version of the Western Aphasia Battery

    Measured: From baseline up to 1-week post training

  2. CANELT

    Cantonese version of the Amsterdam-Nijmegen Everyday Language Test (ANELT; Blomert et al., 1994)

    Measured: From baseline up to 1-week post training

  3. Percentage correct in producing untrained but related scripts

    No written cue will be provided while the PWA will produce the untrained scripts that share similar contexts with the trained scripts.

    Measured: From baseline up to 1-week post training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2022
  2. Study start10 Apr 2023
  3. Primary completion31 Dec 2024
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05667480
Sponsor's protocol ID
P0043271
Status last verified
Aug 2024
First submitted
11 Dec 2022
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The IPD, together with the study protocol, will be shared in an open-access data repository (e.g., Harvard Dataverse).

Questions about this trial

What is this clinical trial studying?

A study testing VR-based script training and Conventional script training in people with Aphasia, Acquired and Chronic Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage correct in reading aloud the sentences included in the trained scripts (time frame: From baseline up to 1-week post training). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.

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